David P. Langlois (DL 2319) SUTHERLAND ... - FDA Law Blog

Case 1:09-cv-04665-DLC Document 49-2 Filed 03/30/2010 Page 39 of 4545. On or about October 20, 2009, Teva submitted comments to FDA in response toSandoz’s Citizen Petition. In that letter, Teva stated, among other things, that the drug productclaims of the ‘584 and ‘404 patents were not and could not be listed in the Orange Book in relationto the NDA for Actos ® . Therefore, Teva maintained, there was no legal basis for requiring Teva tosubmit paragraph IV certifications to those patents.46. On information and belief, or about November 23, 2009, and apparently in responseto Teva’s letter of October 20, 2009, Takeda wrote to FDA “to confirm the listing of two patents”in the Orange Book. The two patents Takeda addresses in this letter are the ‘584 patent and the‘404 patent. More specifically, Takeda wrote in relevant part:As the sponsor of NDA 21-073, Takeda wishes to confirm forFDA the listing of these two patents, under the terms described inTakeda’s original patent submissions.In addition, because these two patents contain both pharmaceuticalcomposition claims and method-of-use claims, Takeda respectfullyrequests that FDA direct any companies that have submittedabbreviated new drug applications (“ANDAs”) referencing Actos ®to submit compete patent certifications to these patents. UnderFDA precedent and practice, a section viii statement alone isinsufficient when a listed patent includes claims other thanmethod-of-use claims. By this letter, and based on the originalsubmission of patent information to the agency, Takeda herebyconfirms that the two patents at issue include claims other thanmethod-of-use claims.”* * *Because the two patents described above contain both drug productcomposition and method-of-use claims, Takeda also respectfullyrequests that FDA contact any ANDA applicants that may havesubmitted only section viii statements regarding one or both ofthese patents, and direct the applicants to submit appropriate patentcertifications. . . . Until proper certifications have been submittedto the ‘584 and ‘404 patents, any ANDAs that lack certifications tothe patents should be regarded as ineligible for tentative or finalapproval.9067383.138